Encouraging results from son of Ibrutinib studies (Acalabrutinib/Calquence)

[AdrianUK]

In case you need any more persuasion that we are in exiting times for the future of CLL, read this article about the exciting results of a drug which all being well may one day replace ibrutinib. Not every promising drug gets all the way through. But when you have a drug with a similar target but hopefully fewer side effects the likelihood of success improves.

cancer.osu.edu/news-and-med...

Title changed so information on Acalabrutinib/Calquence can be found via Search - Admin

[Justasheet1]

It’s already approved for Mantle cell cancer. I’m hoping we’re next this year.

I’m guessing if you’re intolerant to Ibrutinib it will be the go to drug.

[Ladydi49 in reply to Justasheet1]

Do you know the name of the drug?

[Cllcanada Top Poster CURE Hero in reply to Ladydi49]

Calquence (acalabrutinib) should be available in the U.S. fall 2018, but no sure bets.

~chris

[DaleFL in reply to Cllcanada]

For CLL?

[larrymarion in reply to DaleFL]

while not officially approved for CLL by the FDA, it is being prescribed by many docs for patients with R/R CLL who are having problems with ibrutinib. And some insurance companies are approving the Rx for CLL, too.

[bhayes84 in reply to Cllcanada]

Why isn't it available now Chris?

[Cllcanada Top Poster CURE Hero in reply to bhayes84]

Its up to the drug company to start the process for approval, likely they are waiting for more data. Since its already been reviewed by the FDA for safety concerns in the MCL approval, it's easier and faster to get a second indication, CLL second line approved.

I don't know were things stand at the moment, Astrazeneca hasn't given any indications either...

~chris

[CLLCalifornia-USA]

Ibrutinib works well for me so far, but love having another drug on the shelf just in case. Thanks, Sally

[Kwenda]

Good news obviously, less side effects such as AF..

BUT will it be affordable, and can NICE agree a price in the UK that the NHS will also agree to.???

Dick

[Justasheet1 in reply to Kwenda]

Pricing should be in line with Ibrutinib.

[Cllcanada Top Poster CURE Hero in reply to Justasheet1]

Second in class drugs have a rough time, some like ofatumumab fail...simply due to cost. I hope Calquence (acalabrutinib) comes to market at about $90,000 annually, compared to Imbruvica (ibrutinib) at $148,000 it will be a bargain.. win over funders and insurance companies, get it in broad use, then worry about price.

~chris

[AdrianUK in reply to Cllcanada]

Getting the pricing strategy right will be crucial for them. What’s the price for their current indication?

[Cllcanada Top Poster CURE Hero in reply to AdrianUK]

100mg BID, for MCL

The wholesale acquisition cost for Calquence is $14,260 per month, certainly comparable to Imbruvica (ibrutinib), but who knows...

I have no idea of the market size... drug pricing in the U.S. is largely smoke and mirrors.

professionals.optumrx.com/c...

Also see

reference.medscape.com/drug...

~chris

[Ladydi49]

I hope so. I can't take Ibrutinib due to mild cardiac issues so my choices are Bendamustine with Rituxan or Gazyva. Sadly, I think Ibrutinib would work for me😕

[DaleFL in reply to Ladydi49]

Hang in there. It will come.

[SMS-not-cll]

You did it again, AdianUK! Thanks for sending this link.

Our CLL treatments keep improving to give us a brighter future.

Wishing good days and good health to all.

SMS

[mgh348]

I have been on acalabrutinib for 18 months very successfully with few side effects. Truly has been a blessing.

[Corkyrissa in reply to mgh348]

Does your insurance pay for Acalabrutinib or are u on clinical trial? What are the side effects.? I had been on ibrutinib for 19 months and dr stopped it because I’m being monitored for Afib now. Ty

[mgh348 in reply to Corkyrissa]

I'm on a clinical trial at Mayo in Jacksonville. I had headaches and some mild diarrhea for a few weeks. An inflamed finger joint and achy knees for a few months. Hot flashes and blood pressure spikes in the middle of the night, but not sure what was causing them. Now on BP meds and they have stopped.